Additive manufacturing allows for fabrication of parts layer-by-layer. Most additive manufacturing processes are able to manufacture from only a single material, e.g., nylon, or manufacture from only a single type of material, e.g., polymers, metals, etc. Surgical instrument components are frequently assembled from one or more subcomponents manufactured from different materials, e.g., each of the one or more subcomponents may be manufactured by a machining process, a casting process, a molding process, a forming process, a coating process, a joining process, etc. For example, a particular surgical instrument component may be assembled from a housing subcomponent manufactured from an acetal material, a lock subcomponent manufactured from a brass material, and a spring subcomponent manufactured from a stainless steel material. Manufacturing the particular surgical instrument component from a first material by additive manufacturing may cause at least one subcomponent of the particular surgical instrument component to perform in a manner other than as intended. For example, the spring subcomponent manufactured from the first material may have a first Young's modulus and the spring subcomponent manufactured from the stainless steel material may have a second Young's modulus. Accordingly, there is a need for manufacturing a surgical instrument component by additive manufacturing without causing one or more subcomponents of the surgical instrument component to perform in a manner other than as intended.
Manufacturers of medical devices such as surgical instruments are required to comply with ISO, FDA, MEDDEV, and other regulations which require medical device manufacturers to monitor and control suppliers of subcomponents and components. Most medical device manufacturers establish such control over suppliers by conducting periodic audits of a supplier's manufacturing facility. It is common for each subcomponent of each component of a surgical instrument to have a unique supplier. In addition to the burden of regulatory compliance, each individual subcomponent and component of a surgical instrument increases a risk of nonconformance. For example, a component comprising one subcomponent having two critical features has two potential nonconformities, e.g., either one of the two critical features of the one subcomponent could fail. However, a component comprising two subcomponents wherein each of the two subcomponents has two critical features has four potential nonconformities. Accordingly, there is a need to reduce a total number of subcomponents and components of a surgical instrument.